Imricor Medical Systems (IMR) H1 2024 earnings summary

Executive summary

• Achieved Saudi FDA and CE Mark approvals for MRI-compatible cardiac ablation equipment and diagnostic catheters, marking major regulatory milestones.

• World's first and only MRI-compatible platform for cardiac ablations, with two pivotal global trials (VISABL-AFL and VISABL-VT) underway in Europe and the US.

• Expanded global footprint with new hospital installations and first iCMR-guided procedures in Croatia, Hungary, Switzerland, and the US.

• Balance sheet strengthened by successful capital raises, supporting upcoming milestones and commercial expansion.

• Hospital activation momentum re-established, with new sites in Europe and the US.

Financial highlights

• Total revenue for H1 2024 was $408,000, up 105% year-over-year, mainly from equipment and capital sales.

• Net loss for the period was $6.86 million, a 25.6% improvement year-over-year, primarily due to fair value changes in convertible notes and derivatives.

• Operating cash outflow was $8 million, up $1.8 million year-over-year, mainly due to lower accounts payable.

• Cash balance at June 30, 2024, was $1.5 million, with pro forma post-raise balance of $24.8 million if both capital tranches are approved.

• Costs and non-R&D expenses decreased 14% due to lower staffing, insurance, and inventory reserves.

Outlook and guidance

• On track to complete the VISABL-AFL US FDA trial and targeting FDA approval by mid-2025.

• Preparing for the first MRI-guided VT ablation in early Q4, with expected acceleration in hospital adoption and revenue.

• VT trial in Europe expected to complete Q3 2025, with CE Mark approval mid-2026.

• Focus on expanding iCMR-guided ablation market in Europe and new geographies post-pandemic.

• Actively recruiting sales staff to support anticipated demand growth post-VT trial.